Condition category
Pregnancy and Childbirth
Date applied
13/06/2005
Date assigned
25/07/2005
Last edited
28/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

https://www.charttrials.abdn.ac.uk/imop/index.php

Contact information

Type

Scientific

Primary contact

Dr Jane Norman

ORCID ID

Contact details

University of Glasgow Division of Developmental Medicine
3rd Floor
Queen Elizabeth Building
Glasgow Royal Infirmary
10 Alexandra Parade
Glasgow
G31 2ER
United Kingdom
+44 (0)141 211 4708
j.e.norman@clinmed.gla.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RN04OB007

Study information

Scientific title

Acronym

IMOP

Study hypothesis

Outpatient isosorbide mononitrate will result in a shorter inpatient stay before delivery, decreased costs to the health service, and greater maternal satisfaction with induction of labour, compared with placebo treatment

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found at: https://www.charttrials.abdn.ac.uk/imop/pis.php

Condition

Condition - pregnancy,
Indication - cervical ripening prior to induction of labour

Intervention

Isosorbide mononitrate 40 mg (or placebo) given vaginally 48 hours, 32 hours and 16 hours prior to scheduled admission for induction of labour.

Intervention type

Drug

Phase

Not Specified

Drug names

Isosorbide mononitrate (IMN)

Primary outcome measures

i. Elapsed time interval from hospital admission to vaginal delivery (defined as the time from admission for inpatient induction or admission in labour to delivery)
ii. Costs to the health service of induction of labour
iii. Women’s experience of induction of labour

Secondary outcome measures

iv. Operative delivery rates
v. Incidence of unscheduled admission for reasons other than labour commencing
vi. Duration and frequency of neonatal admissions to special care
vii. Incidence of adverse maternal and fetal outcomes such as uterine hypercontractility, postpartum haemorrhage (maternal outcomes) and meconium stained liquor, five minute Apgar of less than seven (fetal outcomes)
viii. Length of labour
ix. Oxytocin augmentation rates
x. Epidural usage
xi. Proportion with unfavourable cervix at 24 hours after admission
xii. Requirement for additional inpatient cervical ripening agent

Overall trial start date

01/02/2005

Overall trial end date

31/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Bishop score less than or equal to 6
2. Singleton pregnancy
3. Nulliparity
4. Gestation greater than or equal to 37 completed weeks
5. Willing to self administer vaginal tablets

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

300

Participant exclusion criteria

Fetal compromise of sufficient severity such that daily fetal monitoring is scheduled

Recruitment start date

01/02/2005

Recruitment end date

31/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Glasgow Division of Developmental Medicine
Glasgow
G31 2ER
United Kingdom

Sponsor information

Organisation

Greater Glasgow Health Board (North Glasgow University Hospitals Division) and The University of Glasgow (UK)

Sponsor details

Research and Development Office
4th Floor
Walton Building
Glasgow Royal Infirmary
84 Castle Street
Glasgow
G4 OSF
United Kingdom
+44 (0)141 211 0475
fiona.graham.gri@northglasgow.scot.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Charity

Funder name

Wellbeing (Charity) Ref. CT 2004

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16869966
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19624440

Publication citations

  1. Results

    Bollapragada S, Mackenzie F, Norrie J, Petrou S, Reid M, Greer I, Osman I, Norman JE, IMOP: randomised placebo controlled trial of outpatient cervical ripening with isosorbide mononitrate (IMN) prior to induction of labour - clinical trial with analyses of efficacy, cost effectiveness and acceptability., BMC Pregnancy Childbirth, 2006, 6, 25, doi: 10.1186/1471-2393-6-25.

  2. Results

    Bollapragada SS, MacKenzie F, Norrie JD, Eddama O, Petrou S, Reid M, Norman JE, Randomised placebo-controlled trial of outpatient (at home) cervical ripening with isosorbide mononitrate (IMN) prior to induction of labour--clinical trial with analyses of efficacy and acceptability. The IMOP study., BJOG, 2009, 116, 9, 1185-1195, doi: 10.1111/j.1471-0528.2009.02216.x.

Additional files

Editorial Notes